Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial

What Was Tested

This randomized controlled trial paper looks at CGRP (Calcitonin Gene-Related Peptide) in the context of migraine.

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults, adults, middle-aged adults and older adults, both men and women.

Randomized, double-blind, placebo-controlled, parallel-group trial conducted at 123 sites in 9 countries from March 23, 2016 (first patient randomized), to April 10, 2017, consisting of a screening visit, 28-day pretreatment period, 12-week treatment period, and final evaluation at week 12.

Study participants were aged 18 to 70 years with episodic migraine (6-14 headache days, with at least 4 migraine days, during 28-day pretreatment period).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and parallel-group study.

Random assignment meant chance, not the researchers, decided who got CGRP (Calcitonin Gene-Related Peptide) and who got the comparison, which limits bias.

Neither the participants nor the staff measuring them knew who was on CGRP (Calcitonin Gene-Related Peptide), so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with CGRP (Calcitonin Gene-Related Peptide) could be set against what happens without it.

Groups ran in parallel: each of the participants stayed in one arm throughout.

The timeline in the abstract includes 28 days.

What Was Measured

The subject headings attached to it are Antibodies, Monoclonal, Calcitonin Gene-Related Peptide and Migraine Disorders.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of CGRP (Calcitonin Gene-Related Peptide) in people with migraine over 28 days.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (JAMA), a journal based in United States.

More context: the CGRP (Calcitonin Gene-Related Peptide) compound page, Migraine research.